Label: MEDI-DERM RX- methyl salicylate, menthol and capsaicin cream

  • NDC Code(s): 76074-151-14
  • Packager: Two Hip Consulting, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 12, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                             

    Capsaicin 0.035%
    Menthol 5%
    Methyl Salicylate 20%

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  • PURPOSE

    PURPOSE

    TOPICAL ANALGESIC

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  • INDICATIONS & USAGE

    USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.

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  • WARNINGS

    Warnings: For external use only.

    • Use only as directed.
    • Avoid contact with eyes and mucous membranes.
    • Do not use with heating devices or pads.
    • Do not cover or bandage tightly.
    • If swallowed, call poison control.
    • If contact does occur with eyes rinse with cold water and call a doctor.
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  • DO NOT USE

    DO NOT USE: ON WOUNDS OR DAMAGED SKIN. CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR. IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT.

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  • DOSAGE & ADMINISTRATION

    Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Carbomer, Cetearyl Alcohol, Cypress Oil, Glyceryl Stearate, Green 3 (CI# 42053), Hypromellose, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol, Polysorbate-60, Propylene Glycol, Sodium Hydroxide, Stearyl Alcohol, Water.

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  • OTHER SAFETY INFORMATION

    OTHER INFORMATION: STORE BELOW 90°F/32°C

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  • QUESTIONS

    QUESTIONS? 888 907-2833

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  • ASK DOCTOR

    IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.

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  • PREGNANCY

    IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

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  • INGREDIENTS AND APPEARANCE
    MEDI-DERM  RX
    methyl salicylate, menthol and capsaicin cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76074-151
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 20 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g  in 100 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.035 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER 934 (UNII: Z135WT9208)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYPERUS ESCULENTUS LEAF (UNII: T1004HC0OF)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76074-151-14 120 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 08/18/2012
    Labeler - Two Hip Consulting, LLC (965352896)
    Registrant - Two Hip Consulting, LLC (965352896)
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